NCT00002084

Brief Summary

To determine the safety and efficacy of oral valacyclovir hydrochloride ( 256U87 ) compared to acyclovir in the treatment of recurrent anogenital herpes in HIV-infected patients with CD4 counts = or \> 100 cells/mm3.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

46 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Keywords

AcyclovirAcquired Immunodeficiency SyndromeAIDS-Related ComplexAntiviral AgentsAnus DiseasesHerpes Genitalis

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have:
  • HIV infection with CD4 counts = or \> 100 cells/mm3.
  • Documented culture of anogenital herpes simplex virus (HSV) within the last 5 years.
  • History of recurrent anogenital HSV infection, with a recurrence (with or without culture) within 1 year prior to study.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Malabsorption or vomiting that would potentially limit the retention and absorption of oral therapy.
  • Concurrent Medication:
  • Excluded:
  • Systemic antiherpes medication.
  • Interferon.
  • Patients with the following prior conditions are excluded:
  • History of hypersensitivity to acyclovir.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (46)

Univ of South Alabama

Mobile, Alabama, 36604, United States

Location

Univ of Arizona / Health Science Ctr

Tucson, Arizona, 85724, United States

Location

Combat Group

Los Angeles, California, 90028, United States

Location

Los Angeles County - USC Med Ctr

Los Angeles, California, 90033, United States

Location

Infectious Disease Med Group / Adult Immunology Clinic

Oakland, California, 94609, United States

Location

UCI Med Ctr

Orange, California, 92668, United States

Location

UCSD Med Ctr

San Diego, California, 92103, United States

Location

San Diego Naval Hosp

San Diego, California, 921345000, United States

Location

ViRx Inc

San Francisco, California, 94103, United States

Location

UCSF - San Francisco Gen Hosp

San Francisco, California, 94110, United States

Location

Dr Marcus Conant

San Francisco, California, 94115, United States

Location

West Haven Veterans Administration Med Ctr

West Haven, Connecticut, 06516, United States

Location

Georgetown Univ Med Ctr

Washington D.C., District of Columbia, 20007, United States

Location

Whitman - Walker Clinic

Washington D.C., District of Columbia, 20009, United States

Location

George Washington Univ Med Ctr

Washington D.C., District of Columbia, 20037, United States

Location

Veterans Administration Med Ctr / Regional AIDS Program

Washington D.C., District of Columbia, 20422, United States

Location

Univ of South Florida

St. Petersburg, Florida, 33705, United States

Location

Emory Univ School of Medicine

Atlanta, Georgia, 30303, United States

Location

AIDS Research Consortium of Atlanta

Atlanta, Georgia, 30308, United States

Location

Northwestern Memorial Hosp

Chicago, Illinois, 60611, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Infectious Diseases Research Clinic / Indiana Univ Hosp

Indianapolis, Indiana, 46202, United States

Location

Univ of Iowa Hosp & Clinic

Iowa City, Iowa, 52242, United States

Location

Univ of Kansas School of Medicine

Wichita, Kansas, 67214, United States

Location

Univ of Maryland at Baltimore

Baltimore, Maryland, 21201, United States

Location

St Paul Ramsey Med Ctr

Saint Paul, Minnesota, 55101, United States

Location

Univ of Mississippi Med Ctr

Jackson, Mississippi, 39216, United States

Location

Univ of Missouri at Kansas City School of Medicine

Kansas City, Missouri, 64108, United States

Location

St Louis Univ

St Louis, Missouri, 63104, United States

Location

Beth Israel Med Ctr

New York, New York, 10003, United States

Location

Saint Vincent's Hosp and Med Ctr

New York, New York, 10011, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Univ of Rochester Med Ctr

Rochester, New York, 14642, United States

Location

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, 97210, United States

Location

Buckley Braffman Stern Med Associates

Philadelphia, Pennsylvania, 19107, United States

Location

Univ of Pittsburgh / Graduate School of Public Health

Pittsburgh, Pennsylvania, 15261, United States

Location

Roger Williams Med Ctr

Providence, Rhode Island, 02908, United States

Location

Regional Med Ctr at Memphis

Memphis, Tennessee, 38103, United States

Location

Dallas Associated Dermatologists

Dallas, Texas, 75246, United States

Location

Univ TX Galveston Med Branch

Galveston, Texas, 77550, United States

Location

Thomas Audetta Clinic

Houston, Texas, 77006, United States

Location

Baylor College of Medicine / Texas Med Ctr

Houston, Texas, 77030, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MacGregor Med Association

Houston, Texas, 77054, United States

Location

Univ TX Med Branch / Ctr for Clinical Studies

Nassau Bay, Texas, 77058, United States

Location

Med College of Virginia

Richmond, Virginia, 232980049, United States

Location

MeSH Terms

Conditions

Herpes SimplexHIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related ComplexAnus DiseasesHerpes Genitalis

Interventions

ValacyclovirAcyclovir

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, MaleMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1996-04

Locations